BMS-247550 in Treating Patients With Advanced Cancers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006221
First received: September 11, 2000
Last updated: February 8, 2013
Last verified: July 2004

September 11, 2000
February 8, 2013
November 2000
June 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006221 on ClinicalTrials.gov Archive Site
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BMS-247550 in Treating Patients With Advanced Cancers
A Phase I Study of BMS-247550 (NSC 710428) Given Weekly X 3 Every 4 Weeks in Patients With Advanced Malignancies

Phase I trial to study the effectiveness of BMS-247550 in treating patients who have malignant solid tumors or lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

OBJECTIVES:

I. Determine the maximum tolerated dose and recommended phase II dose of BMS-247550 in patients with advanced malignancies.

II. Determine the qualitative and quantitative toxic effects of this regimen in these patients.

III. Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.

IV. Determine the antitumor effects of this regimen in these patients.

OUTLINE: This is a dose-escalation study. Patients are stratified according to prior therapy (heavily pretreated vs minimally pretreated).

Patients receive BMS-247550 IV over 1 hour once weekly on weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level. Patients treated at the MTD receive treatment once weekly on weeks 1-3 of each 4-week course.

Patients are followed within 1 month.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoma
  • Small Intestine Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
Drug: ixabepilone
Experimental: Arm I

Patients receive BMS-247550 IV over 1 hour once weekly on weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level. Patients treated at the MTD receive treatment once weekly on weeks 1-3 of each 4-week course.

Intervention: Drug: ixabepilone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
Not Provided
June 2005   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant solid tumor or lymphoma for which no other potentially curative therapeutic option exists or demonstrates increased survival (considering tumor type, stage, and number of prior regimens)
  • No symptomatic brain metastases requiring dexamethasone

    • No progression or cerebral edema on CT scan or MRI within the past 4 weeks

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Neutrophil count at least 1,500/mm^3
  • Hemoglobin at least 8.5 g/dL
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

  • No atrial or ventricular arrhythmias requiring medication
  • No ischemic event within the past 6 months

Other:

  • No pre-existing peripheral neuropathy greater than grade 1
  • No other serious medical illness or active infection that would preclude study participation
  • No dementia, psychiatric illness, or other alteration in mental status that would preclude study compliance
  • No other active malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
  • No history of allergy or hypersensitivity reaction to paclitaxel or other Cremophor EL-containing compound
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after study completion

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
  • No other concurrent chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior anticancer hormonal therapy and recovered
  • No concurrent hormonal therapy except LHRH agonists for non-castrated prostate cancer, contraceptives, hormone replacement therapy (e.g., conjugated estrogens), or megestrol as an appetite stimulant

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered
  • Concurrent palliative radiotherapy to limited sites allowed

Surgery:

  • At least 4 weeks since prior surgery and recovered

Other:

  • At least 30 days since prior investigational agents and recovered
  • No other concurrent experimental medications
  • No concurrent antiretroviral (HAART) therapy for HIV-positive patients
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006221
CDR0000068141, UTHSC-IDD-99-32, SACI-IDD-99-32, NCI-150
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Study Chair: Chris H. Takimoto, MD, PhD, FACP University of Texas Health Science Center at San Antonio
National Cancer Institute (NCI)
July 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP